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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K131783
Device Name POLAROID CONTACTSPOD
Applicant
Viopti, Ltd.
Polaroid Bldg, Vale Of Leven Industrial Estate
Dumbarton,  GB G82 3PW
Applicant Contact EDWIN LINDSAY
Correspondent
Viopti, Ltd.
Polaroid Bldg, Vale Of Leven Industrial Estate
Dumbarton,  GB G82 3PW
Correspondent Contact EDWIN LINDSAY
Regulation Number886.5928
Classification Product Code
LRX  
Date Received06/17/2013
Decision Date 02/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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